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Calliditas Therapeutics AB American Depositary Shares - CALT STOCK NEWS

Welcome to our dedicated page for Calliditas Therapeutics AB American Depositary Shares news (Ticker: CALT), a resource for investors and traders seeking the latest updates and insights on Calliditas Therapeutics AB American Depositary Shares stock.

Calliditas Therapeutics AB (NASDAQ: CALT, Nasdaq Stockholm: CALTX) is a clinical and commercial-stage biopharmaceutical company dedicated to identifying, developing, and commercializing novel treatments specifically targeting orphan indications with significant unmet medical needs, particularly in renal and hepatic diseases. Headquartered in Stockholm, Sweden, Calliditas is pioneering therapies aimed at addressing complex conditions with limited treatment options.

The company's lead product, TARPEYO® (also known as Nefecon outside the United States), is an innovative medication designed to reduce proteinuria in patients suffering from IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys. TARPEYO® has received full approval from the U.S. FDA and conditional marketing authorization in the EU, marking a significant milestone in the treatment landscape for IgAN. Recent data from the ongoing global Phase 3 NefIgArd study and its Open Label Extension (OLE) demonstrate the drug's consistent efficacy and safety profile over an extended period.

Besides TARPEYO®, Calliditas' robust pipeline includes setanaxib, a NOX enzyme inhibitor showing promise in various indications, including squamous cell carcinoma of the head and neck (SCCHN). Recent Phase 2 trial results indicated statistically significant improvements in progression-free survival and overall survival, thus reinforcing the potential of setanaxib in oncological applications.

Calliditas is also expanding its market presence through strategic global partnerships. A notable achievement is the commercial launch of Nefecon in China by its partner, Everest Medicines. This launch is a critical step in addressing the high prevalence and unmet medical needs of IgAN patients in Asia.

Financially, Calliditas continues to strengthen its position, driven by ongoing commercial efforts and strategic equity initiatives. The company remains committed to enhancing shareholder value through advancements in its pipeline, strategic collaborations, and robust operational execution.

News

Calliditas Therapeutics to Attend Investor Conferences in March

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Calliditas Therapeutics AB (Nasdaq: CALT) announces CEO's participation in March 2024 conferences, including Carnegie Healthcare Seminar and Jefferies Biotech Summit. For more details, contact Head of IR & Sustainability, Åsa Hillsten.
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Calliditas Year-end report, January - December 2023

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Calliditas Therapeutics AB (CALT) achieved full approval for TARPEYO in the US in 2023, marking a successful year. Net sales and operating income increased in Q4 2023 compared to Q4 2022. Cash decreased, but net sales and TARPEYO sales saw significant growth in 2023. The company anticipates revenue growth in 2024.
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Invitation to the presentation of Calliditas´ Year-end report January - December 2023

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Calliditas to release Year-end report for January - December 2023 with CEO and CFO participation. Webcast and conference call details provided.
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Calliditas provides patent update

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Calliditas Therapeutics AB (CALT) secures a new patent for TARPEYO in the US, extending product protection until 2043. The patent covers treatment of IgA nephropathy with NEFECON, showcasing the company's commitment to innovation and global expansion.
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Calliditas Therapeutics provides business update ahead of JP Morgan conference

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Calliditas Therapeutics AB (CALT) provided a business update for the fourth quarter of 2023, reporting strong Q4 preliminary product revenue growth with net TARPEYO revenues of $31 – 33m for the quarter, representing significant growth over Q3. Preliminary Net TARPEYO revenues of $100 – 102m for 2023, representing over 170% year over year growth compared to 2022. Preliminary Total revenues reaching $110 – 113m for 2023, as a result of milestone payments and royalty income from the Nefecon franchise outside the US. The company also achieved a record quarter in terms of enrollments with 555 new TARPEYO prescriptions in the 4th quarter.
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Calliditas Therapeutics appoints Maria Törnsén as President North America

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Calliditas Therapeutics AB (CALT) appoints Maria Törnsén as President North America, announces full FDA approval of TARPEYO®, and targets top line read out of several Phase 2 clinical trials with setanaxib in 2024.
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Calliditas to present at JP Morgan Healthcare Conference

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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 9th, 2024, providing an update on the company.
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Calliditas refinances existing term loan with Euro 92 million senior secured facility with Athyrium Capital

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Calliditas Therapeutics AB (CALT) secures 92 million Euro term loan with Athyrium Capital Management, LP, extending debt repayment by 3 years and ensuring continued access to non-dilutive capital. The loan will be used to fully repay the existing 68 million Euro loan with Kreos Capital, with the principal amount of the new loan being 24 million Euros greater than that of the prior facility.
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Everest Medicines' Partner Calliditas Therapeutics Announces Nefecon® the Only FDA-approved Treatment for IgA Nephropathy to Significantly Slow Kidney Function Decline

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Everest Medicines (HKEX 1952.HK) licensing partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) announced that the U.S. FDA has fully approved Nefecon® delayed release capsules for adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. Nefecon® demonstrated a significant benefit over placebo in reducing kidney function loss, with a 50% less deterioration in kidney function compared to placebo over a 2-year period. The drug is also approved in China and showed a greater treatment effect in the Chinese subpopulation compared to the global population. Nefecon® is considered a revolutionary therapeutic option for IgAN patients, offering a disease-modifying treatment with sustained and clinically meaningful reduction in eGFR declines and proteinuria. The drug's approval represents a significant milestone for Everest Medicines and its partner Calliditas Therapeutics AB, with plans for a China launch in 2024.
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Calliditas Therapeutics announces full FDA approval of TARPEYO®, the only FDA-approved treatment for IgA nephropathy to significantly reduce the loss of kidney function

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Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) announced FDA approval of TARPEYO (budesonide) to reduce kidney function loss in adults with primary IgAN. TARPEYO is the first fully FDA-approved treatment for IgAN based on a measure of kidney function, showing a 50% reduction in kidney function deterioration in TARPEYO-treated patients compared to placebo-treated patients over a 2-year period.
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FAQ

What is the current stock price of Calliditas Therapeutics AB American Depositary Shares (CALT)?

The current stock price of Calliditas Therapeutics AB American Depositary Shares (CALT) is $40.0001 as of September 20, 2024.

What is the market cap of Calliditas Therapeutics AB American Depositary Shares (CALT)?

The market cap of Calliditas Therapeutics AB American Depositary Shares (CALT) is approximately 1.1B.

What does Calliditas Therapeutics AB specialize in?

Calliditas specializes in identifying, developing, and commercializing novel treatments for orphan indications, particularly focusing on renal and hepatic diseases with significant unmet medical needs.

What is TARPEYO?

TARPEYO® is a medication developed by Calliditas Therapeutics designed to reduce proteinuria in patients with IgA nephropathy (IgAN). It has received full approval from the U.S. FDA and conditional marketing authorization in the EU.

Where is Calliditas Therapeutics headquartered?

Calliditas Therapeutics is headquartered in Stockholm, Sweden.

Who are some of Calliditas' partners?

Calliditas partners with Everest Medicines for the commercial launch of Nefecon in China and collaborates globally to expand its market presence.

What recent advancements has Calliditas made?

Recent advancements include positive Phase 3 study results for TARPEYO, the commercial launch of Nefecon in China, and promising Phase 2 trial results for setanaxib in treating squamous cell carcinoma of the head and neck.

What is setanaxib?

Setanaxib is a NOX enzyme inhibitor in Calliditas' pipeline, showing significant improvements in progression-free survival and overall survival in a Phase 2 trial for squamous cell carcinoma of the head and neck.

How is Calliditas maintaining financial health?

Calliditas strengthens its financial position through ongoing commercial efforts, strategic global partnerships, and equity initiatives, ensuring robust operational execution and shareholder value enhancement.

What are the key highlights of the OLE study in the NefIgArd trial?

The Open Label Extension (OLE) study in the NefIgArd trial showed consistent treatment response in reducing proteinuria and stabilizing eGFR at 9 months, irrespective of previous treatments, confirming the safety and efficacy of Nefecon.

How does TARPEYO work?

TARPEYO is an oral delayed-release budesonide formulation targeting mucosal B-cells in the ileum, which are responsible for producing galactose-deficient IgA1 antibodies that cause IgA nephropathy.

What are the upcoming milestones for Calliditas?

Upcoming milestones for Calliditas include further clinical data readouts from ongoing trials, regulatory submissions for full approvals, and expanding market reach through strategic partnerships.

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Calliditas Therapeutics AB American Depositary Shares

Nasdaq:CALT

CALT Rankings

#2459 Ranked by Market Cap
N/A Ranked by Dividends

CALT Stock Data

1.09B
27.02M
3.81%
0.32%
0.01%
Biotechnology
Healthcare
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United States of America
Stockholm